FDA approves Cotellic-Zelboraf combination to treat advanced melanoma

Source: Pharmaceutical Technology.com, November 2015

The US Food and Drug Administration (FDA) has granted approval for Roche’s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) to treat people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

The company noted that both Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene.

Cotellic is the company’s seventh new medicine approved by the FDA in the past five years.

The approval is based on results from the Phase III coBRIM study, which showed Cotellic plus Zelboraf reduced the risk of disease worsening or death by about half in people who received the combination, with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone.